Senior Clinical Data Manager - Data Strategy & Delivery

BioSpace; Indiana (PA); On-site; USD 116,000 - 187,000; Full time

Benefits offered by this job

401(k)

Pension

Medical, dental, vision benefits

Job summary

Lilly in the US is seeking a Senior Clinical Data Manager to lead planning and execution of data management activities across global development programs, delivering high-quality, timely data and supporting pivotal regulatory submissions.

This hands-on role partners with CROs and vendors, oversees data systems (EDC, IRT, ePRO, ECG), drives CDISC/CDASH standards, and ensures data integrity and inspection readiness in a fast-paced, collaborative environment.

Qualifications

• 6+ years of hands-on clinical data management experience in pharma/biotech.
• Expert knowledge of electronic clinical data systems and multiple vendor EDC platforms.
• Experience managing CROs and technical vendors with oversight of deliverables and timelines.
• Strong regulatory knowledge for submissions (Pre-IND, IND, NDA/BLA).
• Experience supporting CNS, oncology, and/or rare disease trials is a plus.

Responsibilities

• Lead planning and execution of clinical data management activities to support global development programs, ensuring high-quality, timely, and cost-effective delivery
• Develop and oversee data management strategies and plans, including data capture tool design, data processing, coding, validation, and ongoing data quality oversight.
• Establish and maintain clinical data systems and infrastructure, including the identification, set-up, testing, and technical oversight of electronic clinical trial technologies (e.g., EDC, IRT, ePRO, ECG, and other external data sources).
• Drive data standards strategy and compliance, providing guidance across the data continuum and ensuring adherence to CDISC/CDASH standards to support regulatory submissions.
• Partner closely with internal stakeholders and external CRO and technology vendors to align on requirements, timelines, deliverables, and performance expectations.
• Provide oversight of vendor technology platforms and processes, ensuring they meet regulatory, quality, and inspection-readiness requirements for global development programs.
• Develop and manage data management documentation, including data management plans, data transfer plans, and validated automated data flows for internal and external data.
• Monitor timelines, milestones, and deliverables, proactively communicating risks, metrics, and status to cross-functional teams and leadership.
• Generate and review in-process data reports and listings to support trial oversight and decision-making, including safety and data review activities.
• Provide data management input into clinical and regulatory documents, including protocols, protocol amendments, clinical study reports, and statistical analysis plans.
• Ensure data integrity, quality, and regulatory compliance, supporting GCP inspection readiness across all data management domains.
• Contribute to the development of best practices, SOPs, and scalable data management processes to support a growing clinical portfolio.

Skills

Clinical data management

CDISC/CDASH standards

Vendor management

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in a relevant field

Tools

EDC platforms

ePRO

IRT

Data management systems

Job description

Lilly in the US is seeking a Senior Clinical Data Manager to lead planning and execution of data management activities across global development programs, delivering high-quality, timely data and supporting pivotal regulatory submissions.

This hands-on role partners with CROs and vendors, oversees data systems (EDC, IRT, ePRO, ECG), drives CDISC/CDASH standards, and ensures data integrity and inspection readiness in a fast-paced, collaborative environment.